Registry-based randomised clinical trials : a remedy for evidence-based diabetes care?

• This narrative review describes a new approach to navigation in a challenging landscape of clinical drug development in diabetes. Successful outcome studies in recent years have led to new indications and guidelines in type 2 diabetes, yet the number of clinical trials in diabetes is now declining. This is due to many environmental factors acting in concert, including the prioritisation of funding for other diseases, high costs of large randomised clinical trials, increase in regulatory requirements and limited entry of novel candidate drugs. There is a need for novel and cost-effective paradigms of clinical development to meet these and other challenges. The concept of registry-based randomised clinical trials (RRCTs) is an attractive option. In this review we focus on type 2 diabetes and the prevention of cardiovascular and microvascular comorbidities and mortality, using the Swedish SMARTEST trial as an example of an RRCT. We also give some examples from other disease areas. The RRCT concept is a novel, cost-effective and scientifically sound approach for conducting large-scale diabetes trials in a real-world setting.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)

Keyword

Clinical outcomes

First-line treatment

Glucose-lowering drugs

Healthcare registry

Macrovascular complications

Microvascular complications

Mortality

Randomised trial

Review

Type 2 diabetes

Clinical outcomes

First-line treatment

Glucose-lowering drugs

Healthcare registry

Macrovascular complications

Microvascular complications

Mortality

Randomised trial

Review

Type 2 diabetes

Publication and Content Type

ref (subject category)

for (subject category)